MAUDE Adverse Event Report: MAX MOBILITY LLC SMARTDRIVE

Model Number	MX2+
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Remains Activated (1525); Failure to Shut Off (2939)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Permobil ab received a report where it was alleged that while using the smartdrive with switch control button w/mono jack and a buddy button, the controls were reportedly off yet claims the device engaged a drive command, involuntarily, which forced the end-user to collide into an immovable object where they lost positioning and fell from the wheelchair.The fall reportedly required a hospital visit, but the extent of injury and level of medical intervention was not disclosed.Permobil ab has requested further information from reporter, but has yet to receive any response at this time.The smartdrive device and controller was reportedly retreived by the provider for inspection, but no information has been provided to permobil ab as to their findings.Permobil ab has requested suspect components be returned to permobil ab for further evaluation.At this time, permobil ab is unable to reach a determination as to possible root cause without specualtion.Upon receipt of any new information, a follow-up report will be submitted.
Event or Problem Description
Received report claiming as the end-user was using the smartdrive device with a switch control button w/mono jack and buddy button, reported that the device had been switched off, but the end-user's wheelchair reportedly took off and couldn't be stopped.The end-user had to crash into a bin in order to stop it.It was further reported that the client fell from the wheelchair where they reportedly sustained an unspecified injury requiring medical intervention to address.

• Brand Name: SMARTDRIVE
• Common Device Name: SMARTDRIVE
• Manufacturer (Section D): MAX MOBILITY LLC; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): MAX MOBILITY LLC; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 25285057
• Report Number: 3008370857-2026-00340
• Device Sequence Number: 18663414
• Product Code: ITI
• UDI-Device Identifier: 00861896000310
• UDI-Public: (01)00861896000310(11)230215
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K151199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MX2+
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown